MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065753048

Device Problem Device Alarm System (1012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported a system message was displayed at the end of silicone extraction.The surgeon restarted the system and a second system message was displayed.The facility does not have a back up system so the surgeon had to complete the silicon extraction passively so some silicone remains in the eye and the patient will need a second surgery.

Manufacturer Narrative

The company service representative examined the system and did not replicate the reported event.The company service representative confirmed the system messages (sm) reported in the event log.The pneumatic module was replaced as a prevention.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The pneumatic module was received for evaluation.The pneumatic module was tested and met specifications.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9762568
• MDR Text Key: 181815404
• Report Number: 2028159-2020-00154
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Required Intervention